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510(k) Data Aggregation
K Number
K211159Device Name
eco-x Series (eco-x, eco-x-s)
Manufacturer
HDX WILL Corp.
Date Cleared
2021-12-30
(255 days)
Product Code
OAS
Regulation Number
892.1750Why did this record match?
Applicant Name (Manufacturer) :
HDX WILL Corp.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
'eco-x series (eco-x, eco-x-s)' is 4 in 1 digital equipment that provides CT, Panoramic, Cephalometric, and Model Scan images by using X-Ray scan. It provides 2D images for diagnosing cranial bone tissue including adult and pediatric teeth, jaw, oral structures and skull. Also, it provides 3D images by reconstructing images acquired by capturing cervical bone and occipital regions.
In addition, 'eco-x series' is used as diagnosis for general and/or orthodontic treatment, and also is intended to use for ENT (Ear, Nose, and Throat) and dentomaxillofacial diagnosis.
Device Description
This Equipment is a Dental X-Ray imaging device used for diagnostic purpose in dental treatment. The operating principle of this device is obtaining the tomographic images by rotating arm to get the recombination data, X-ray generator and detector rotate around the patient to irradiate the X-ray, and penetrated X-ray is measured by the detector, When the X-ray is irradiated on the teeth area for instance, large amount of X-ray is attenuated because objects such as bones are highly dense, On the contrast, X-ray is more permeable to small molecules with low density such as skin or tissue, so more X-ray would pass through the subject. By measuring data obtained from measuring the X-ray is reconstructed by the software to display and analyze the anatomical structure for the diagnosis purposes.
The eco-x Series consists of 2 different models. The eco-x-s supports cephalometric scan compared with the eco-x, which do not support CEPH mode.
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K Number
K211114Device Name
Will3D
Manufacturer
HDX WILL CORP.
Date Cleared
2021-12-15
(245 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
HDX WILL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Will3D is a software application used for the display and 3D visualization of medical image files from scanning devices, such as Dental CT scanner. It is intended for use by radiologists, clinicians, referring physicians and other qualified individuals to retrieve, process, render, store, print, assist in diagnosis, and distribute images utilizing standard PC hardware. Additionally, Will3D is a preoperative software application and evaluation and evaluation of dental implants, orthodontic planning and surgical treatments.
Device Description
Will3D is one of the components of a Picture Archiving and Communications System(PACS). Will3D is the software application that provides image viewing and manipulation in the diagnostic imaging setting.
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K Number
K212254Device Name
DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa)
Manufacturer
HDX Will Corp.
Date Cleared
2021-10-19
(92 days)
Product Code
OAS
Regulation Number
892.1750Why did this record match?
Applicant Name (Manufacturer) :
HDX Will Corp.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DENTRIa series is a Computed Tomography X-Ray imaging device specialized in diagnosing general dental treatments and orthodontic purpose using Panoramic and Cephalometric images respectively. In addition DENTRIC series is used in the field of Otolaryngology by capturing 360 degree rotation sequence of the head and neck areas, including the ENT and dentomaxillofacial areas for a dental treatment in adult and pediatric dentistry and obtains x-ray images from different angles and calculate through computer-processed to produce 3D x-ray tomographic images. The DENTRIC series used by physicians, dentists, and x-ray technologists.
Device Description
This Equipment is a Dental X-Ray imaging device used for diagnostic purpose in dental treatment. The operating principle of this device is obtaining the tomographic, and panoramic images by rotating arm to get the recombination data. X-ray generator and detector rotate around the patient to irradiate the X-ray, and penetrated X-ray is measured by the detector. When the X-ray is irradiated on the teeth area for instance, large amount of X-ray is attenuated because objects such as bones are highly dense. On the contrast, X-ray is more permeable to small molecules with low density such as skin or tissue, so more X-ray would pass through the subject. By measuring data obtained from measuring the X-ray is reconstructed by the software to display and analyze the anatomical structure for the diagnosis purposes.
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K Number
K192700Device Name
Xcam
Manufacturer
HDX WILL Corp.
Date Cleared
2019-12-27
(92 days)
Product Code
EHD
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
HDX WILL Corp.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This X-ray Unit is intended to be used in portable applications, by a qualified/trained dentist or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of dental structures.
Device Description
The Xcam is a portable X-ray for taking diagnostic radiographic exposures of body parts and operates on 11.1V DC supplied by a battery. Xcam is composed of x-ray generator including x-ray tubes, equipment controller, power controller, user interface and x-ray collimator. Xcam can be used with an imaging sensor. The image receptor, necessary component for a fully functional x-ray system, is not part of the submitted device.
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K Number
K190357Device Name
Star-X, Intraoral X-ray System
Manufacturer
HDX WILL Corp.
Date Cleared
2019-03-15
(28 days)
Product Code
EHD
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
HDX WILL Corp.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Star-X is intra-oral X-ray system for dental diagnosis that can radiate X-ray images by irradiating X-rays generated by high voltage to an anode in an X-ray tube and reacting with the receptor (film, sensor).
Star-X is a dental X-ray equipment (extra-oral source system) intended for use by qualified dentist or dental technician for both adult and pediatric patient for producing diagnostic dental radiographs for treatment of diseases of the teeth, jaw, and other oral structures using intra-oral image receptors.
Device Description
The Star-X is an X-ray generator for dental intra-oral X-ray imaging and intended to be used for producing diagnostic dental radiographs for treatment of disease of teeth, jaw and oral structures. The Star-X is consisted of X-ray generator, beam limiting device (cone), control panel, mechanical arm, support device, chair and backrest. The control panel allows for accurate exposure control and adjustable arm provide for convenient patient positioning.
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K Number
K181297Device Name
DENTIOIII series (DENTIOIII, DENTIOIII-S)
Manufacturer
HDX WILL CORP.
Date Cleared
2018-11-21
(189 days)
Product Code
MUH
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
HDX WILL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DENTIOIII series is intended for dental radiographic examination of the teeth and temporomandibular joints, specifically for panoramic and cephalometric examinations. It is to be used only by dental practitioners and/or radiologists
Device Description
This equipment is a dental X-ray imaging device used for diagnostic purposes in dental examination. The operating principle of this device is obtaining the panoramic images by rotating the arm to get the recombination data, having the X-ray generator and detector rotate around the patient to irradiate the X-ray, and measuring the penetrated X-ray using the detector. When the X-ray irradiates the teeth area for instance, a large amount of X-ray is attenuated because objects such as bones are highly dense. By contrast, the X-ray permeates more through small molecules with low density such as skin or tissue measuring the X-ray is reconstructed by the software for display and analysis, the anatomical structure can be viewed for the diagnosis purposes. In addition, the Cephalo arm uses the scanning method.
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K Number
K172168Device Name
WillCeph
Manufacturer
HDX WILL CORP.
Date Cleared
2018-03-21
(246 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
HDX WILL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
WillCeph is intended for use by specialized dental practices for capturing, storing and presenting patient images and radiographs and to aid in cephalometric analysis, orthodontic treatment planning and case follow-up. Results produced by the software tools are to be interpreted by trained and licensed dental practitioners.
Device Description
WillCeph is a software device for Cephalometric Analysis & Maxillo-facial Surgical Simulation, Consulting, Diagnosis, Surgical Planning, Analysis, Growth Forecast. It includes features for patient data management, various gallery formats, image fusion and comparing, cephalogram and tracing on digitized X-ray film, treatment simulation (VTO / STO), chart and analysis, superimposition, photo-film image fusion, growth forecast, and PACS integration (Option). It can be used as a client or standalone software on Microsoft Windows 7 or higher.
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K Number
K170180Device Name
Will3D
Manufacturer
HDX WILL CORP.
Date Cleared
2017-05-08
(109 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
HDX WILL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Will3D is a software application used for the display and 3D visualization of medical image files from scanning devices, such as Dental CT scanner. It is intended for use by radiologists, clinicians, referring physicians and other qualified individuals to retrieve, process, render, review, store, print, assist in diagnosis, and distribute images utilizing standard PC hardware. Additionally, Will3D is a preoperative software application used for the simulation and evaluation of dental implants, orthodontic planning and surgical treatments.
Device Description
The Will3D is one of the components of a PACS (Picture Archiving and Communications System). The Will3D is the software application that provides image viewing and manipulation in the diagnostic imaging setting.
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K Number
K160140Device Name
DENTRIa series
Manufacturer
HDX WILL CORP.
Date Cleared
2016-09-30
(253 days)
Product Code
OAS, MUH
Regulation Number
892.1750Why did this record match?
Applicant Name (Manufacturer) :
HDX WILL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DENTRIα series is a Computed Tomography X-Ray imaging device specialized in diagnosing general dental treatments and orthodontic purpose using Panoramic and Cephalometric images respectively. In addition DENTRIα series is used in the field of Otolaryngology by capturing 360 degree rotation sequence of the head and neck areas, including the ENT and dentomaxillofacial areas for a dental treatment in adult and pediatric dentistry and obtains x-ray images from different angles and calculate though computer-processed to produce 3D x-ray tomographic images. The DENTRIα series is used by physicians, dentists, and x-ray technologists.
Device Description
This Equipment is a Dental X-Ray imaging device used for diagnostic purpose in dental treatment. The operating principle of this device is obtaining the tomographic images by rotating arm to get the recombination data, X-ray generator and detector rotate around the patient to irradiate the X-ray, and penetrated X-ray is measured by the detector, When the X-ray is irradiated on the teeth area for instance, large amount of X-ray is attenuated because objects such as bones are highly dense, On the contrast, X-ray is more permeable to small molecules with low density such as skin or tissue, so more X-ray would pass through the subject. By measuring data obtained from measuring the X-rav is reconstructed by the software to display and analyze the anatomical structure for the diagnosis purposes.
The DENTRIα Series are classified as shown below.
DENTRIa: CT Mode + PANORAMA Mode
DENTRI-Ca: CT Mode + PANORAMA Mode + CEPHALO Mode (ONE-SHOT)
DENTRI-Sa: CT Mode + PANORAMA Mode + CEPHALO Mode (SCAN)
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